Evidence map›Paper›PMID 20525992›Full record

Trial reportThe New England journal of medicine2010

Improved survival with ipilimumab in patients with metastatic melanoma.

F Stephen Hodi, Steven J O'Day, David F McDermott, Robert W Weber, Jeffrey A Sosman, John B Haanen, Rene Gonzalez, Caroline Robert, Dirk Schadendorf, Jessica C Hassel and 19 more

Erratum issued 23 registry-linked trialsOpen access · greenAbstract readClinical Trial, Phase IIIComparative StudyMulticenter Study
In one paragraph

Trial report in The New England journal of medicine, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to 23 registered trials, which are not on this map. Cited by 7,707 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7,707citing papers in PubMed, 3 pooled it
251.0field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00094653 phase3completednot on this map

A Randomized, Double-Blind, Multicenter Study Comparing MDX-010 Monotherapy, MDX-010 in Combination With a Melanoma Peptide Vaccine, and Melanoma Vaccine Monotherapy in HLA-A2*0201-Positive Patients With Previously Treated Unresectable Stage III or IV Melanoma

TypeinterventionalSponsorBristol-Myers SquibbRan2004 to 2009Enrolled1,783ConditionsMelanoma, MetastasesArmsMDX-010 (anti-CTLA4) monoclonal antibody, MDX-1379 (gp100) Melanoma Peptide Vaccine
NCT01363206 phase2completednot on this mapstarted 2011, after this paper: background citation

GM-CSF and Ipilimumab as Therapy in Metastatic Melanoma, a Phase II Study

TypeinterventionalSponsorLynn E. Spitler, MDRan2011 to 2015Enrolled29ConditionsMalignant Melanoma, MetastaticArmsGranulocyte-Macrophage Colony Stimulating Factor (GM-CSF), Ipilimumab
NCT01654692 phase2completednot on this map

A Phase II Study of the Combination of Ipilimumab and Fotemustine in Patients With Unresectable Locally Advanced or Metastatic Malignant Melanoma

TypeinterventionalSponsorItalian Network for Tumor BiotherapyRan2010 to 2014Enrolled86ConditionsMetastatic Malignant MelanomaArmsIpilimumab and Fotemustine
NCT01703507 phase1completednot on this mapstarted 2012, after this paper: background citation

Phase I Study of Ipilimumab Combined With Whole Brain Radiation Therapy or Radiosurgery for Melanoma Patients With Brain Metastases

TypeinterventionalSponsorSidney Kimmel Comprehensive Cancer Center at Thomas Jefferson UniversityRan2012 to 2018Enrolled17ConditionsRecurrent Melanoma, Stage IV Melanoma, Tumors Metastatic to BrainArmsIpilimumab, Whole-Brain Radiation Therapy (WBRT), Stereotactic Radiosurgery (SRS)
NCT02259621 phase2active not recruitingnot on this mapstarted 2014, after this paper: background citation

Neoadjuvant Nivolumab, or Nivolumab in Combination With Ipilimumab, in Resectable Non-Small-Cell Lung Cancer.

TypeinterventionalSponsorSidney Kimmel Comprehensive Cancer Center at Johns HopkinsRan2014 to 2027Enrolled39ConditionsNon-Small Cell Lung CancerArmsNivolumab, Carboplatin, Paclitaxel, Ipilimumab
NCT02318771 phase1completednot on this mapstarted 2015, after this paper: background citation

An Exploratory Study to Investigate the Immunomodulatory Activity of Radiation Therapy (RT) in Combination With MK-3475 in Patients With Recurrent/Metastatic Head and Neck, Renal Cell Cancer, Melanoma and Lung Cancer

TypeinterventionalSponsorSidney Kimmel Comprehensive Cancer Center at Thomas Jefferson UniversityRan2015 to 2021Enrolled41ConditionsHead and Neck Squamous Cell Carcinoma, Metastatic Renal Cell Cancer, Recurrent Head and Neck Carcinoma, Recurrent Lung CarcinomaArmsRadiation Therapy (RT), MK-3475
NCT02533895 phase1completednot on this map

Monocyte-derived Dendritic Cells Loaded With Tumour Cell Lysates for the Treatment of Refractory Solid Tumours of Childhood

TypeinterventionalSponsorActivartis BiotechRan2000 to 2015Enrolled67ConditionsChildhood Solid TumorArmsAV0113 DC-CIT, Data evaluation
NCT02583516 phase2completednot on this mapstarted 2015, after this paper: background citation

A Randomized Phase II Study of Vemurafenib Plus Cobimetinib Continuous Versus Intermittent, in Previously Untreated BRAFV600- Mutation Positive Patients With Unresectable Locally Advanced or Metastatic Melanoma

TypeinterventionalSponsorGrupo Español Multidisciplinar de MelanomaRan2015 to 2019Enrolled70ConditionsMelanomaArmsvemurafenib and cobimetinib
NCT03160079 phase1 / phase2completednot on this mapstarted 2017, after this paper: background citation

A Phase I/II Study of Blinatumomab in Combination With Pembrolizumab (MK-3475) for Adults With Relapsed or Refractory B-lineage Acute Lymphoblastic Leukemia With High Bone Marrow Lymphoblast Percentage

TypeinterventionalSponsorUniversity of California, San DiegoRan2017 to 2023Enrolled16ConditionsB-Cell Acute Lymphoblastic Leukemia, AdultArmsblinatumomab, pembrolizumab
NCT03233152 phase1 / phase2active not recruitingnot on this mapstarted 2016, after this paper: background citation

A Phase I/II Clinical Trial on the Per-operative Intratumoral Administration of Myeloid Dendritic Cells Plus Ipilimumab and Nivolumab, Followed by Repeated Intracavitary Plus Intravenous Administration of Nivolumab in Patients With Recurrent Glioblastoma

TypeinterventionalSponsorUniversitair Ziekenhuis BrusselRan2016 to 2026Enrolled110ConditionsGlioblastomaArmsIpilimumab (YervoyTM, 50 mg/10 mL solution), Nivolumab (OpdivoTM, 40 mg/4mL solution), Autologous CD1c(BDCA-1)+ /CD141(BDCA-3)+ myDC
NCT03447678 phase2unknown statusnot on this mapstarted 2018, after this paper: background citation

Phase II Study to Test Pembrolizumab (MK-3475) in First Line Treatment of Advanced NSCLC Patients With PD-L1 Low Tumors (<50%)_ PEOPLE TRIAL (Pembrolizumab in Pd-L1 Low Expressors).

TypeinterventionalSponsorFondazione IRCCS Istituto Nazionale dei Tumori, MilanoRan2018 to 2022Enrolled65ConditionsNon Small Cell Lung Cancer (NSCLC)ArmsPembrolizumab
NCT03498196 phase1 / phase2terminatednot on this mapstarted 2018, after this paper: background citation

A Window of Opportunity Trial: Avelumab in Non-metastatic Muscle Invasive Bladder Cancer (BL-AIR: Bladder Cancer-Avelumab for Invasive Resectable Disease)

TypeinterventionalSponsorBaylor College of MedicineRan2018 to 2019Enrolled1ConditionsBladder Cancer, Metastatic Bladder Cancer, Invasive Bladder CancerArmsAvelumab
NCT03651271 phase2completednot on this mapstarted 2018, after this paper: background citation

An Exploratory Study of Nivolumab With or Without Ipilimumab According to the Percentage of Tumoral CD8 Cells in Participants With Advanced Metastatic Cancer

TypeinterventionalSponsorParker Institute for Cancer ImmunotherapyRan2018 to 2023Enrolled100ConditionsAdvanced Metastatic Cancer, Advanced Prostate CancerArmsNivolumab Monotherapy, Nivolumab and Ipilimumab and Combination for Metastatic Cancer, Nivolumab and Ipilimumab (3 mg/kg) Combination for Prostate Cancer, Nivolumab and Ipilimumab (5 mg/kg) Combination for Prostate Cancer
NCT03817125 phase1completednot on this mapstarted 2019, after this paper: background citation

A Multicenter Phase 1b Randomized, Placebo-controlled, Blinded Study to Evaluate the Safety, Tolerability and Efficacy of Microbiome Study Intervention Administration in Combination With Anti-PD-1 Therapy in Adult Patients With Unresectable or Metastatic Melanoma

TypeinterventionalSponsorParker Institute for Cancer ImmunotherapyRan2019 to 2022Enrolled14ConditionsMetastatic MelanomaArmsPlacebo for antibiotic, Vancomycin pretreatment, Nivolumab, Matching Placebo for SER-401, SER-401
NCT03832621 phase2completednot on this mapstarted 2019, after this paper: background citation

NIVOLUMAB Plus IPILIMUMAB and TEMOZOLOMIDE in Combination in Microsatellite Stable (MSS), MGMT Silenced Metastatic Colorectal Cancer (mCRC): the MAYA Study

TypeinterventionalSponsorFondazione IRCCS Istituto Nazionale dei Tumori, MilanoRan2019 to 2021Enrolled135ConditionsMetastatic Colorectal CancerArmsTemozolomide, Nivolumab, Ipilimumab
NCT03918252 phase2active not recruitingnot on this mapstarted 2019, after this paper: background citation

Neoadjuvant Immune Checkpoint Blockade in Resectable Malignant Pleural Mesothelioma

TypeinterventionalSponsorSidney Kimmel Comprehensive Cancer Center at Johns HopkinsRan2019 to 2028Enrolled30ConditionsMesotheliomaArmsNivolumab Injection, Ipilimumab Injection
NCT04141644 phase1active not recruitingnot on this mapstarted 2020, after this paper: background citation

A Phase Ib Study to Evaluate the Safety and Efficacy of Osimertinib in Combination With Ipilimumab in Patients With EGFR Mutated Non-Small-Cell Lung Cancer Tumors

TypeinterventionalSponsorUniversity of UtahRan2020 to 2028Enrolled24ConditionsNon-Small Cell Lung Cancer With Mutation in Epidermal Growth Factor Receptor (Disorder)ArmsIpilimumab, Osimertinib
NCT04663126 early_phase1terminatednot on this mapstarted 2021, after this paper: background citation

Pilot Study to Test the Feasibility of IV Injected Tc-99m-tilmanocept for Imaging of M2-like Tumour Associated Macrophages in Metastatic Melanoma

TypeinterventionalSponsorJohn O. PriorRan2021 to 2023Enrolled5ConditionsMelanomaArmsTc-99m tilmanocept
NCT04730999 phase2completednot on this mapstarted 2020, after this paper: background citation

A Phase II, Single Arm Study of CarbopLatin Plus Etoposide With Bevacizumab and Atezolizumab in Patients With exTEnded-disease Small-cell Lung Cancer (SCLC)

TypeinterventionalSponsorGruppo Oncologico Italiano di Ricerca ClinicaRan2020 to 2024Enrolled54ConditionsSmall Cell Lung CancerArmsEtoposide, Carboplatin, Bevacizumab, Atezolizumab
NCT05185505 phase4recruitingnot on this mapstarted 2023, after this paper: background citation

Atezolizumab and Bevacizumab Pre-Liver Transplantation for Patients With Hepatocellular Carcinoma Beyond Milan Criteria: A Feasibility Study

TypeinterventionalSponsorThe Methodist Hospital Research InstituteRan2023 to 2027Enrolled24ConditionsHepatocellular Carcinoma, Hepatocellular CancerArmsAtezolizumab, Bevacizumab
NCT05715229 phase2recruitingnot on this mapstarted 2023, after this paper: background citation

A Multicenter Phase II Randomized Trial Of Immunotherapy Versus Chemotherapy Guided By Circulating Tumor DNA-Based Molecular Response On Patients With Metastatic NSCLC

TypeinterventionalSponsorHackensack Meridian HealthRan2023 to 2027Enrolled108ConditionsCarcinoma, Non-Small-Cell LungArmsNivolumab, Ipilimumab, Carboplatin, Paclitaxel, Pemetrexed
NCT06416436 phase1withdrawnnot on this mapstarted 2024, after this paper: background citation

Immunotherapy in Combination With Ablative Radiosurgery to Ultra-high DoSes (ICARUS): A Phase I Dose-escalation Radiosurgery Study in Metastatic Cancers

TypeinterventionalSponsorUniversity of Kansas Medical CenterRan2024 to 2024Enrolled0ConditionsSolid TumorArmsAtezolizumab, Stereotactic Ablative Radiotherapy (SBRT)
NCT06566391 phase2unknown statusnot on this mapstarted 2019, after this paper: background citation

Primary Ipilimumab and Nivolumab Combo-immunotherapy Followed by Adjuvant Nivolumab in Locally Advanced or Limited Metastatic Melanoma

TypeinterventionalSponsorEuropean Institute of OncologyRan2019 to 2024Enrolled35ConditionsMelanomaArmsIpilimumab
3 · Its place in the literature

Who cites it

7,707 citing papers in PubMed, 3 syntheses or guidelines pooled it, 15,037 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
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  5. Circulating Thymidine Kinase Activity Predicts Survival and Optimal Treatment Sequencing in BRAF-Mutated Metastatic Melanoma in the SECOMBIT Trial.Clinical cancer research : an official journal of the American Association for Cancer Research · 2026
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7,647 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

29 authors at 20 institutions in 7 countries.

F Stephen HodiDana-Farber Cancer Institute, Boston, MA 02115, USA. stephen_hodi@dfci.harvard.edu
Steven J O'Day
David F McDermott
Robert W Weber
Jeffrey A Sosman
John B Haanen
Rene Gonzalez
Caroline Robert
Dirk Schadendorf
Jessica C Hassel
Wallace Akerley
Alfons J M van den Eertwegh
Jose Lutzky
Paul Lorigan
Julia M Vaubel
Gerald P Linette
David Hogg
Christian H Ottensmeier
Celeste Lebbé
Christian Peschel
Ian Quirt
Joseph I Clark
Jedd D Wolchok
Jeffrey S Weber
Jason Tian
Michael J Yellin
Geoffrey M Nichol
Axel Hoos
Walter J Urba
Essen University Hospital · DEPrincess Margaret Hospital · NZAmsterdam UMC Location VUmc · NLAngeles Clinic and Research Institute · USBristol-Myers Squibb (United States) · USGerman Cancer Research Center · DEHadassah Medical Center · ILHampton University · USHarvard University · USHuntsman Cancer Institute · USInstitut Gustave Roussy · FRLoyola University Medical Center · USMemorial Sloan Kettering Cancer Center · USMoffitt Cancer Center · USProvidence Portland Medical Center · USSaint Louis University Hospital · USSylvester Comprehensive Cancer Center · USThe Christie Hospital · GBThe Netherlands Cancer Institute · NLUniversity of Colorado Denver · US

Funding

Clinical Investigation in Tumor ImmunotherapyK24CA097588 · NCI · VANDERBILT UNIVERSITY · PI SOSMAN, JEFFREY A · 2002 to 2012
$1.5M
NCI NIH HHS K24 CA097588
6 · The paper itself

Abstract

backgroundAn improvement in overall survival among patients with metastatic melanoma has been an elusive goal. In this phase 3 study, ipilimumab--which blocks cytotoxic T-lymphocyte-associated antigen 4 to potentiate an antitumor T-cell response--administered with or without a glycoprotein 100 (gp100) peptide vaccine was compared with gp100 alone in patients with previously treated metastatic melanoma.

methodsA total of 676 HLA-A*0201-positive patients with unresectable stage III or IV melanoma, whose disease had progressed while they were receiving therapy for metastatic disease, were randomly assigned, in a 3:1:1 ratio, to receive ipilimumab plus gp100 (403 patients), ipilimumab alone (137), or gp100 alone (136). Ipilimumab, at a dose of 3 mg per kilogram of body weight, was administered with or without gp100 every 3 weeks for up to four treatments (induction). Eligible patients could receive reinduction therapy. The primary end point was overall survival.

resultsThe median overall survival was 10.0 months among patients receiving ipilimumab plus gp100, as compared with 6.4 months among patients receiving gp100 alone (hazard ratio for death, 0.68; P<0.001). The median overall survival with ipilimumab alone was 10.1 months (hazard ratio for death in the comparison with gp100 alone, 0.66; P=0.003). No difference in overall survival was detected between the ipilimumab groups (hazard ratio with ipilimumab plus gp100, 1.04; P=0.76). Grade 3 or 4 immune-related adverse events occurred in 10 to 15% of patients treated with ipilimumab and in 3% treated with gp100 alone. There were 14 deaths related to the study drugs (2.1%), and 7 were associated with immune-related adverse events.

conclusionsIpilimumab, with or without a gp100 peptide vaccine, as compared with gp100 alone, improved overall survival in patients with previously treated metastatic melanoma. Adverse events can be severe, long-lasting, or both, but most are reversible with appropriate treatment. (Funded by Medarex and Bristol-Myers Squibb; ClinicalTrials.gov number, NCT00094653.)

Indexed as

Antibodies, MonoclonalAntigens, CDCancer VaccinesCombined Modality TherapyCTLA-4 AntigenDouble-Blind MethodFemaleHumansIpilimumabKaplan-Meier EstimateMaleMelanomaMiddle AgedSkin NeoplasmsTreatment OutcomeAntibodies, MonoclonalAntigens, CDCancer VaccinesCTLA-4 AntigenCTLA4 protein, humangp100(209-2M) vaccineIpilimumab

Identifiers

PMID20525992
PMCPMC3549297
OpenAlexW2097995306

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

and 17 more above

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.